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510(k) K182891

TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants by Cs Medical, LLC — Product Code PSW

K182891 is an FDA 510(k) premarket notification submitted by Cs Medical, LLC for the device "TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants". The FDA issued a decision of Substantially Equivalent on April 12, 2019. The device falls under product code PSW (High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid), a Class II device regulated under 21 CFR 892.1570. Cs Medical, LLC has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2019
Date Received
October 15, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid
Device Class
Class II
Regulation Number
892.1570
Review Panel
HO
Submission Type

To provide high level disinfection of ultrasound transducers If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Cs Medical, LLC

  • K233049 — TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with (November 21, 2023)
  • K230381 — Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High- (June 7, 2023)
  • K192228 — CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD- (April 1, 2020)
  • K160921 — CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Me (November 3, 2016)
  • K051305 — CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD (August 18, 2005)
  • K050381 — CS MEDICAL TTCF GAS DELIVERY SYSTEM (July 13, 2005)
  • K050379 — CS MEDICAL ADULT TTCF CATHETER (July 12, 2005)

Other clearances for product code PSW

  • K233049 — TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with (November 21, 2023)
  • K230381 — Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High- (June 7, 2023)
  • K192228 — CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD- (April 1, 2020)
  • K160921 — CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Me (November 3, 2016)
  • K150504 — GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endore (November 16, 2015)
  • K051305 — CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD (August 18, 2005)

FDA data resources